Head of Quality

SRG; Newcastle upon Tyne; Sur place; GBP 90 000 - 120 000; Plein temps

Résumé du poste

SRG in the Northeast of England is seeking a Head of Operational Quality & Formulation to lead the Quality and Formulation teams, ensuring GMP-compliant release of Specials products. You will oversee product release processes, stability programmes, and MHRA compliance, driving timely release and continuous improvement while partnering with procurement on starting materials and formulations.

Registration with the GPhC is essential.

Qualifications

• Registration with the General Pharmaceutical Council (GPhC) is essential.
• Proven experience in pharmaceutical formulation, QA, or manufacturing.
• Excellent knowledge of GMP, GDP, and MHRA Specials guidance.
• Experience in deviation investigations, risk assessments, and change control management.

Responsabilités

• Oversee quality release, stability monitoring, and compliance across operations.
• Act as Quality Controller on MHRA Specials license for the site.
• Lead quality teams to ensure timely product release per GMP and SOPs.
• Monitor batch release timelines, right-first-time rates, and issue resolution turnaround.
• Lead monthly performance reviews and improve batch review workflows.
• Manage new product introductions from feasibility to production readiness.
• Design and oversee stability programs and root cause investigations.
• Ensure GMP, GDP, MHRA compliance and support audits and change controls.

Formation

GPhC registration

Description du poste

Head of Operational Quality & Formulation

Location: Northeast England

SRG are partnered with an established pharmaceutical manufacturer in the Northeast to find a Head of Operational Quality and Formulation. The company are leaders in the manufacture of Specials, supplying hard-to-source products to the patients who need them.

This is a key technical, quality leadership position overseeing the quality and timely release of life saving products.

The Role

As the head of Operational Quality & Formulation, you will be lead the Quality and Formulation teams ensuring the quality & compliance of manufactured Specials products allowing them to reach the patients who need them.

Key duties will include:

• Oversight of the product release processes, stability monitoring programmes, and compliance systems across manufacturing operations.
• Acting as Quality Controller on the Manufacturers' Specials License for the site in line with MHRA requirements.
• Overseeing quality teams and processes to ensure timely release of products in compliance with GMP, internal SOPs, and regulatory standards.
• Monitoring key quality release metrics, including batch release timelines, right-first-time rates, and turnaround times for issue resolution.
• Leading monthly performance reviews, contributing to site-level Quality Manager Review forums, and identifying bottlenecks to streamline batch review workflows.
• Managing new product introductions from technical feasibility to production readiness, including working with procurement on starting materials and formulations.
• Designing and overseeing stability programs, owning product lifecycle data, and leading root cause investigations and CAPAs.
• Maintaining compliance with GMP, GDP, and MHRA regulations, supporting audits, and contributing to product quality reviews and change controls.

Requirements

• Registration with the General Pharmaceutical Council (GPhC) is essential.
• Proven experience in a similar position within pharmaceutical formulation, QA, or manufacturing.
• Excellent knowledge of GMP, GDP, and MHRA Specials guidance.
• Experience in deviation investigations, risk assessments, and change control management.